Specialist Qa
Job Opportunity: Specialist QA
📍 Location: Juncos, PR
🕒 100% Onsite | 2nd Shift and Non-Standard Shifts (including nights and weekends)
📆 Contract Duration: Approximately one year
About ProQuality Network
ProQuality Network is dedicated to connecting highly skilled professionals with exceptional opportunities in the pharmaceutical and biotechnology industries. With a focus on quality and excellence, we collaborate with leading organizations to deliver top-tier talent that drives success and innovation. This opportunity is offered through a contract with ProQuality Network.
Position Summary
We are seeking a Specialist QA to support our client’s Quality Assurance program by performing key quality functions with minimal supervision. The ideal candidate is a quality professional with experience in Manufacturing Process Audits, Batch Record Reviews, and familiarity with systems such as DAI, PASx/MES applications, MAXIMO, SAP, and LIMS.
Educational Requirements
- Doctorate Degree or
- Master’s Degree and 3 years of directly related experience or
- Bachelor’s Degree and 5 years of directly related experience or
- Associate’s Degree and 10 years of directly related experience or
- High School Diploma/GED and 12 years of directly related experience.
Preferred Qualifications
- Experience in Manufacturing Process Audits and Batch Record Review.
- Familiarity with DAI processes, PASx/MES applications, MAXIMO, SAP, and LIMS.
- Availability for non-standard shifts, including nights and weekends.
Key Responsibilities
- Review and approve product Master Production Records (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Serve as a Quality representative on incident triage teams.
- Approve Environmental Characterization reports and release sanitary utility systems.
- Approve planned incidents and represent QA on NPI teams.
- Lead investigations, site audits, and quality program procedures.
- Serve as QA designee on local CCRB and review risk assessments.
- Support automation activities, facilities, and environmental programs.
- Review and approve Work Orders, EMS/BMS alarms, NC investigations, CAPA records, and change controls.
- Provide lot disposition and authorize product shipments.
Competencies and Skills
- Strong project management and organizational skills.
- Ability to lead cross-functional teams and influence stakeholders.
- In-depth knowledge of manufacturing processes, quality assurance, validation, and process development.
- Expertise in interacting with regulatory agencies and advanced data trending and evaluation.
- Proficiency in word processing, presentation, database, and spreadsheet applications.
- Excellent communication, facilitation, and presentation skills.
- Ability to work independently and collaboratively at all organizational levels.
Why Join Us?
This role offers an exciting opportunity to contribute to the highest quality standards in pharmaceutical manufacturing. As a Specialist QA, you’ll play a pivotal role in ensuring compliance, driving quality improvements, and supporting innovation in a world-class organization.
📧 Interested candidates are encouraged to apply inside the job description with an updated resume.
Be part of something exceptional. Let’s build excellence together! 🌟